Sanitas SBM 03 Instructions For Use Manual page 22

• This device is in line with the EU Medical Devices
Directive 93/42/EC, the "Medizinproduktegesetz"
(German Medical Devices Act) and the standards
EN 1060-1 (non-invasive sphygmomanometers, Part
1: General requirements), EN 1060-3 (non-invasive
sphygmomanometers, Part3: Supplementary require-
ments for electro-mechanical blood pressure measur-
ing systems) and IEC 80601-2-30 (Medical electrical
equipment – Part 2-30: Particular requirements for the
safety and essential performance of automated non-
invasive blood pressure monitors).
• The accuracy of this blood pressure monitor has been
carefully checked and developed with regard to a long
useful life.
If using the device for commercial medical purposes,
it must be regularly tested for accuracy by appropri-
ate means. Precise instructions for checking accuracy
may be requested from the service address.
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